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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04146363

Registration number

NCT04146363

Ethics application status

Date submitted

29/10/2019

Date registered

31/10/2019

Date last updated

30/11/2022

Titles & IDs

Public title

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

Scientific title

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

Secondary ID [1]

2019-002932-10

Secondary ID [2]

17801

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atopic Dermatitis

Condition category

Condition code

Skin

Dermatological conditions

Skin

Other skin conditions

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Other interventions - Lebrikizumab
Other interventions - Placebo

Placebo Comparator: Placebo - Induction Period (Baseline-Week 16):
Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.
Maintenance Period (Week 16-Week 52):
Two placebo SC injections as loading dose on Week 16 and Week 18. One placebo SC injection Q2W until Week 50.

Experimental: Lebrikizumab 250 Q2W - Induction Period (Baseline-Week 16):
500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14.
Maintenance Period (Week 16-Week 52):
One 250 mg Lebrikizumab SC injection Q2W until Week 50.
For participants who received placebo in the Induction Period, the maintenance loading dose is:
Two 250 mg Lebrikizumab SC injections on Week 16.
Two 250 mg Lebrikizumab SC injections on Week 18.
To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is:
One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16.
One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.

Experimental: Lebrikizumab 250 Q4W - Maintenance Period (Week 16-Week 52):
One 250 mg Lebrikizumab SC injection every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48.
One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50.
For participants who received placebo in the Induction Period, the maintenance loading dose is:
Two 250 mg Lebrikizumab SC injections on Week 16.
Two placebo injections on Week 18.
To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is:
One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16.
Two placebo injections on Week 18

Experimental: Escape Arm (Lebrikizumab Q2W) - Maintenance Period (Week 16-Week 52):
Blinded loading doses based on prior treatment assignment will be administered, followed by one 250 mg Lebrikizumab SC injection Q2W until Week 50 in an open-label fashion.
For participants who received placebo in the Induction Period, the loading dose is:
Two 250 mg Lebrikizumab SC injections on Week 16.
Two 250 mg Lebrikizumab SC injections on Week 18.
To maintain the loading dose blind, for participants who received Lebrikizumab in the Induction Period, the loading dose is:
One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18.
For participants who do not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses will be administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.

Other interventions: Lebrikizumab
Subcutaneous injection

Other interventions: Placebo
Subcutaneous Injection

Intervention code [1]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16

Timepoint [1]

Baseline to Week 16

Primary outcome [2]

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (=75% Reduction in EASI Score) From Baseline to Week 16

Timepoint [2]

Baseline to Week 16

Secondary outcome [1]

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 2

Timepoint [1]

Baseline to Week 2

Secondary outcome [2]

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 4

Timepoint [2]

Baseline to Week 4

Secondary outcome [3]

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 in Adults

Timepoint [3]

Baseline to Week 16

Secondary outcome [4]

Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) From Baseline to Week 16

Timepoint [4]

Baseline to Week 16

Secondary outcome [5]

Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Timepoint [5]

Baseline, Week 16

Secondary outcome [6]

Percentage of Participants With a Pruritus NRS Score of =4-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Timepoint [6]

Baseline to Week 16

Secondary outcome [7]

Percentage of Participants With a Pruritus NRS Score of =5-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16

Timepoint [7]

Baseline to Week 16

Secondary outcome [8]

Percent Change in EASI Score From Baseline to Week 16

Timepoint [8]

Baseline, Week 16

Secondary outcome [9]

Change From Baseline in Percent Body Surface Area (BSA) at Week 16

Timepoint [9]

Baseline, Week 16

Secondary outcome [10]

Percentage of Participants Achieving EASI-90 From Baseline to Week 4

Timepoint [10]

Baseline to Week 4

Secondary outcome [11]

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Timepoint [11]

Baseline, Week 16

Secondary outcome [12]

Percentage of Participants Achieving =4 Point Improvement in DLQI From Baseline to Week 16

Timepoint [12]

Baseline to Week 16

Secondary outcome [13]

Percentage of Participants With a DLQI Total Score of =4-point at Baseline Achieving =4-point Improvement in DLQI From Baseline to Week 16

Timepoint [13]

Baseline to Week 16

Secondary outcome [14]

Percent Change in Sleep-loss Score From Baseline to Week 16

Timepoint [14]

Baseline, Week 16

Secondary outcome [15]

Change From Baseline in Sleep-loss Score at Week 16

Timepoint [15]

Baseline, Week 16

Secondary outcome [16]

Percentage of Participants With a Sleep-loss Score =2 Points at Baseline Who Achieve a =2 Points Reduction From Baseline at Week 16

Timepoint [16]

Baseline to Week 16

Secondary outcome [17]

Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1

Timepoint [17]

Baseline to Week 1

Secondary outcome [18]

Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2

Timepoint [18]

Baseline to Week 2

Secondary outcome [19]

Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4

Timepoint [19]

Baseline to Week 4

Secondary outcome [20]

Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1

Timepoint [20]

Baseline to Week 1

Secondary outcome [21]

Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2

Timepoint [21]

Baseline to Week 2

Secondary outcome [22]

Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4

Timepoint [22]

Baseline to Week 4

Secondary outcome [23]

Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

Timepoint [23]

Baseline, Week 16

Secondary outcome [24]

Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52

Timepoint [24]

Predose: Baseline, Week 4, Week 16, Week 32, Week 52

Secondary outcome [25]

Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)

Timepoint [25]

Baseline to Week 52

Secondary outcome [26]

Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a =2-point Improvement From Baseline at Week 16 Who Continue to Exhibit and IGA 0 or 1 and a =2-point Improvement From Baseline at Week 52

Timepoint [26]

Baseline to Week 52

Secondary outcome [27]

Percentage of Participants From Those With a Pruritus NRS of =4-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52

Timepoint [27]

Baseline to Week 52

Secondary outcome [28]

Percentage of Participants From Those With a Pruritus NRS of =5-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52

Timepoint [28]

Baseline to Week 52

Secondary outcome [29]

Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52

Timepoint [29]

Baseline, Week 52

Secondary outcome [30]

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index

Timepoint [30]

Baseline, Week 16

Secondary outcome [31]

Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)

Timepoint [31]

Baseline, Week 16

Secondary outcome [32]

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Timepoint [32]

Baseline, Week 16

Secondary outcome [33]

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents

Timepoint [33]

Baseline, Week 16

Secondary outcome [34]

Change From Baseline in PROMIS Depression at Week 16 - Adolescents

Timepoint [34]

Baseline, Week 16

Secondary outcome [35]

Change From Baseline in PROMIS Anxiety at Week 16 - Adults

Timepoint [35]

Baseline, Week 16

Secondary outcome [36]

Change From Baseline in PROMIS Depression at Week 16 - Adults

Timepoint [36]

Baseline, Week 16

Secondary outcome [37]

Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma

Timepoint [37]

Baseline, Week 16

Secondary outcome [38]

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents

Timepoint [38]

Baseline, Week 16

Eligibility

Key inclusion criteria

- Male or female adults and adolescents (=12 years and =40 kg)

- Chronic atopic dermatitis (according to American Academy of Dermatology Consensus
Criteria) that has been present for =1 year before the screening visit

- Eczema Area and Severity Index (EASI) score =16 at the baseline visit

- Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit

- =10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit

- History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable

Minimum age

12 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Prior treatment with dupilumab or tralokinumab

- Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4
inhibitors such as crisaborole within 1 week prior to the baseline visit

- Treatment with any of the following agents within 4 weeks prior to the baseline visit:

- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors,
azathioprine, methotrexate, etc.)

- Phototherapy and photochemotherapy (PUVA) for AD

- Treatment with the following prior to the baseline visit:

- An investigational drug within 8 weeks or within 5 half-lives (if known) of
baseline, whichever is longer

- Cell-depleting biologics, including to rituximab, within 6 months of baseline

- Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever
is longer

- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study

- Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g.,
co-morbid severe uncontrolled asthma

- Evidence of active acute or chronic hepatitis

- History of human immunodeficiency virus (HIV) infection or positive HIV serology

- History of malignancy, including mycosis fungoides, within 5 years before the
screening visit, except completely treated in situ carcinoma of the cervix, completely
treated and resolved non-metastatic squamous or basal cell carcinoma of the skin

- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

24/09/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

3/05/2022

Sample size

Target

Accrual to date

Final

424

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC,WA

Recruitment hospital [1]

The St. George Hospital - Kogarah

Recruitment hospital [2]

Holdsworth House Medical Practice - Sydney

Recruitment hospital [3]

Skin & Cancer Foundation Australia - Westmead

Recruitment hospital [4]

The Skin Centre - Benowa

Recruitment hospital [5]

Veracity Clinical Research Pty Ltd - Woolloongabba

Recruitment hospital [6]

Eastern Clinical Research Unit - Box Hill

Recruitment hospital [7]

Emeritus Research - Camberwell

Recruitment hospital [8]

Skin Health Institute Inc. - Carlton

Recruitment hospital [9]

Sinclair Dermatology - East Melbourne

Recruitment hospital [10]

Fremantle Dermatology - Fremantle

Recruitment hospital [11]

Burswood Dermatology - Victoria Park

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2010 - Sydney

Recruitment postcode(s) [3]

2145 - Westmead

Recruitment postcode(s) [4]

4217 - Benowa

Recruitment postcode(s) [5]

4102 - Woolloongabba

Recruitment postcode(s) [6]

3128 - Box Hill

Recruitment postcode(s) [7]

3124 - Camberwell

Recruitment postcode(s) [8]

3053 - Carlton

Recruitment postcode(s) [9]

3002 - East Melbourne

Recruitment postcode(s) [10]

6160 - Fremantle

Recruitment postcode(s) [11]

06100 - Victoria Park

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arkansas

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

Connecticut

Country [4]

United States of America

State/province [4]

Florida

Country [5]

United States of America

State/province [5]

Georgia

Country [6]

United States of America

State/province [6]

Indiana

Country [7]

United States of America

State/province [7]

Kentucky

Country [8]

United States of America

State/province [8]

Massachusetts

Country [9]

United States of America

State/province [9]

Michigan

Country [10]

United States of America

State/province [10]

Missouri

Country [11]

United States of America

State/province [11]

Nevada

Country [12]

United States of America

State/province [12]

New Hampshire

Country [13]

United States of America

State/province [13]

New York

Country [14]

United States of America

State/province [14]

North Carolina

Country [15]

United States of America

State/province [15]

Oklahoma

Country [16]

United States of America

State/province [16]

Oregon

Country [17]

United States of America

State/province [17]

Rhode Island

Country [18]

United States of America

State/province [18]

Texas

Country [19]

United States of America

State/province [19]

Washington

Country [20]

Canada

State/province [20]

Alberta

Country [21]

Canada

State/province [21]

Ontario

Country [22]

Estonia

State/province [22]

Tartu

Country [23]

France

State/province [23]

Cedex 10

Country [24]

France

State/province [24]

Bordeaux Cedex

Country [25]

France

State/province [25]

Dijon Cedex

Country [26]

France

State/province [26]

Martigues

Country [27]

France

State/province [27]

Toulouse cedex 9

Country [28]

Korea, Republic of

State/province [28]

Gyeonggi-do

Country [29]

Korea, Republic of

State/province [29]

Korea

Country [30]

Korea, Republic of

State/province [30]

Kyung Gi-Do, Korea

Country [31]

Korea, Republic of

State/province [31]

Yongsan-gu

Country [32]

Korea, Republic of

State/province [32]

Incheon

Country [33]

Korea, Republic of

State/province [33]

Seoul

Country [34]

Latvia

State/province [34]

Riga

Country [35]

Latvia

State/province [35]

Talsi

Country [36]

Lithuania

State/province [36]

Kaunas

Country [37]

Lithuania

State/province [37]

Vilnius

Country [38]

Poland

State/province [38]

Malopolska

Country [39]

Poland

State/province [39]

Malopolskie

Country [40]

Poland

State/province [40]

Mazowieckie

Country [41]

Poland

State/province [41]

Slaskie

Country [42]

Poland

State/province [42]

West Pomeranian

Country [43]

Poland

State/province [43]

Wojewodztwo Podkarpackie

Country [44]

Poland

State/province [44]

Katowice

Country [45]

Poland

State/province [45]

Krakow

Country [46]

Poland

State/province [46]

Lublin

Country [47]

Poland

State/province [47]

Poznan

Country [48]

Poland

State/province [48]

Warszawa

Country [49]

Poland

State/province [49]

Wroclaw

Country [50]

Spain

State/province [50]

Barcelona

Country [51]

Spain

State/province [51]

Vizcaya

Country [52]

Spain

State/province [52]

Alicante

Country [53]

Spain

State/province [53]

Badalona

Country [54]

Spain

State/province [54]

Madrid

Country [55]

Spain

State/province [55]

Sevilla

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Eli Lilly and Company

Address

Country

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Dermira, Inc.

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52
weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab
as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week
induction treatment period and a 36-week long-term maintenance treatment period.

Trial website

https://clinicaltrials.gov/ct2/show/NCT04146363

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Address

Eli Lilly and Company

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04146363